ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 12MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Model Number D12LT |
Device Problems
Loose or Intermittent Connection (1371); Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.Date of event is 2020.Event day and event month was not reported.Attempts are being made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
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Event Description
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It was reported that during an unknown procedure, the device's safety lock failed.There were no patient consequences.No additional information is available at this time.
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Manufacturer Narrative
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(b)(4).Date sent: 4/13/2020.D4: batch # r9573n.Investigation summary: the analysis results found that the d12lt device was returned with no damage in the external components.During the functional testing, the bullet retracted, permitting the exposure of the blade during the advancement through the skin test media and returned to safe position upon penetration.The bullet performed as intended without any anomalies noted.It could not be determined what may have caused the event reported.The event described could not be confirmed as the device performed without any difficulties noted.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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Search Alerts/Recalls
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